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The SleepRight® ProRx® Custom Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Protection against teeth grinding, bruxism and jaw clenching.

Short-term pain relief from muscle spasm due to occlusal interference.

For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The SleepRight® ProRx® Custom Dental Guard is a full occlusal custom formable protector that provides a barrier between the upper and lower teeth. Contains a hard core material enveloped by a moldable thermoplastic. The guard is heated in hot (not boiling) water until it becomes malleable and then formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls are gently pushed up to surround the teeth. The material hardens in roughly one minute. The SleepRight® ProRx® Custom Dental Guard has a tensile strength of 29 Mpa and a Shore D hardness value comparable to the primary predicate device, the ProTech Dent®.

The provided text describes a 510(k) submission for a dental guard. It does not contain information about a medical device that uses artificial intelligence or requires a study with acceptance criteria and reported device performance in the way typically expected for AI/ML-based devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a comparative evaluation of physical properties, wear and abrasion resistance, and biocompatibility of the SleepRight® ProRx® Custom Dental Guard against predicate devices. The "performance data" section states:

• "Comparative evaluation of the physical properties of the materials of construction of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device, the ProTech Dent®."
• "Comparative wear and abrasion resistance testing of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device the ProTech Dent®"
• "Biocompatibility testing: Cytotoxicity (ISO 10993 - 5), Sensitization and Irritation (ISO 10993 - 10)"

The conclusion states that the device "has the same indications for use, same materials of construction, same technological characteristics, and the same principles of operation as the predicate devices," thereby establishing substantial equivalence.

Given this, I cannot provide the requested information formatted for AI/ML device studies because the provided document does not pertain to such a device or study type. The "acceptance criteria" and "device performance" are focused on material properties and biological safety as compared to predicate devices, not on diagnostic accuracy metrics.

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As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxillofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

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The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary and FDA clearance letter for a medical device (CLR 2940 Erbium CrystaLase).

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Continuum Biomedical CB Erbium/2.94), rather than presenting a performance study against predefined acceptance criteria. The clearance letter confirms that the device is substantially equivalent to legally marketed devices based on the indications for use.

Therefore, I cannot populate the requested tables and information as no such details are present in the provided text. The document states: "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns," which is a statement of belief for substantial equivalence, not a report of a study against acceptance criteria.

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